Novartis gets FDA OK for faster flu vaccine production at U.S. plant

Novartis ($NVS) will use a process to manufacture its seasonal flu vaccine at its new plant in Holly Springs, NC, that is based on animal cell cultures and so will cut weeks off production times.

The FDA approved the approach for Novartis Flucelvax a few days ago, saying it provides "the potential for a faster startup of the vaccine manufacturing process in the event of a pandemic." The method is used to make other kinds of vaccines. Novartis has received about $500 million in support from the U.S. government for the Holly Springs plant as part of a program that gives the government say over production in the event of a pandemic. Novartis says the joint investment in the technology and plant is about $1 billion.

The Swiss company will use a cell-culture system derived from the kidney of a dog, The Wall Street Journal said. Using mammal cells will shave about four weeks off the process compared with using eggs and eliminates the need to keep a stock of eggs. Novartis uses the same process at a plant in Germany. Novartis says the North Carolina plant will be the first of its kind in the U.S.

"Modern cell-culture technology will likely become the new standard for influenza vaccine production and we are proud to lead the way," said Andrin Oswald, who heads the Novartis vaccines and diagnostics division.

The company said Flucelvax, which is approved for adults, does not contain any preservatives, such as thimerosal, or antibiotics and will be produced in sterile rooms to reduce the risk of impurities. Novartis pointed out that traditional influenza vaccine production requires a large number of fertilized chicken eggs to grow virus strains and takes months "for organization of egg supplies, virus incubation and actual production before the vaccine" is ready for delivery. It said cell-culture technology is successfully used to manufacture vaccines, including those distributed during the H1N1 pandemic, as well as vaccines for polio, rubella and hepatitis A5,6. The process will be initiated at the Holly Springs plant.

- read the Wall Street Journal story (sub. req.)
- here's the Novartis release
- and here's the FDA announcement